Pharma, known for biosimilars, nears an immunotherapy battle with big pharma

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https://www.biopharmadive.com/news/coherus-junshi-immunotherapy-lung-cancer/605275/

Coherus, known for biosimilars, nears an immunotherapy battle with big pharma​

Published Aug. 19, 2021

Ben Fidler

 

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Dive Brief:​

• Coherus Biosciences and China's Junshi Biosciences on Wednesday said their experimental immunotherapy succeeded in a Phase 3 trial in non-small cell lung cancer and that they aim to seek approval of the drug in the U.S., China and elsewhere.
• Interim results show the drug toripalimab, when combined with chemotherapy, kept tumors from spreading for a median of 8.3 months, versus 5.6 months for chemotherapy alone. The trial hasn't gone on long enough to prove the combination helped patients live longer, though the trend currently favors treatment with the Junshi and Coherus drug.
• The results could position Coherus, best known as a maker of copycat biologic drugs, to become the next entrant in oncology's most competitive market. Its commercial prospects are unclear, however, as Merck & Co.'s Keytruda has become the standard of care for most patients and drugs from Roche, partners Regeneron and Sanofi and others are fighting for market share.

 

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Dive Insight:​

After spending years developing biosimilars, Coherus broadened its ambitions in February. Using the profits generated from a copycat version of Amgen's Neulasta, the company bought partial rights to Junshi's drug, marking its first foray into innovative medicines.
Coherus executives signaled the deal was part of a transition to "Coherus 2.0," using its biosimilar cash to fund a pipeline of experimental cancer immunotherapies. Toripalimab, a so-called checkpoint inhibitor that works similarly to Keytruda, Bristol Myers Squibb's Opdivo and others, is meant to be the linchpin of that effort.
Already approved in China for melanoma, the drug is in testing for a dozen different tumor types, among them cancers of the breast, lung and liver. Coherus aims to use toripalimab, along with options for other Junshi oncology assets or deals with other companies, to develop multi-drug combinations. Its first step is a U.S. approval filing in nasopharyngeal carcinoma, a submission that is currently underway. With the results disclosed Wednesday morning, lung cancer might be next.
Toripalimab's U.S. arrival could, in theory, represent an opportunity to launch a lower-priced checkpoint inhibitor, which have six-figure annual price tags even though there are now seven available. Costs could keep rising, too, as multiple checkpoint inhibitors are progressing from their original approvals in advanced disease to earlier lines of care, where many existing treatments are generic and cheap.
Coherus hasn't specifically divulged its pricing plans, though some analysts expect the company to undercut others. "We believe ... Coherus is really going to make the PD-1 game about access and working with providers differently," wrote Mizuho analyst Salim Syed, in February, "in part [with] price cuts."
EQRx, a well-funded startup with grand ambitions, is planning a similar strategy, having licensed its own checkpoint inhibitor from China's C-Stone Pharmaceuticals.
But Coherus' drug has to pass muster with U.S. regulators first, and that's not a certainty. The trials supporting its use in nasopharyngeal carcinoma and lung cancer were each run in China. Coherus doesn't expect to need to run "bridging studies" to secure approval, though management acknowledged such a requirement depends on the FDA and hasn't been discussed yet, Syed wrote in July.
Coherus plans to meet with the FDA "to discuss a potential submission," the company said in a statement Wednesday.
Syed wrote that Junshi's drug "seems to line up fairly well" against Merck's Keytruda given the Phase 3 result. But it's unclear how the two exactly compare. Regulators first approved the Keytruda-chemotherapy combination in 2018. Junshi's lung cancer trial began afterwards, but tested toripalimab and chemotherapy against an outdated comparator — a strategy for which Regeneron, whose drug Libtayo was approved in lung cancer this year, has already drawn criticism.
Coherus shares climbed 7% in early trading Wednesday.

 

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After spending years developing biosimilars, Coherus broadened its ambitions in February. Using the profits generated from a copycat version of Amgen's Neulasta, the company bought partial rights to Junshi's drug, marking its first foray into innovative medicines.

Shifting strategy, Coherus buys rights to experimental cancer drug​

Published Feb. 1, 2021

Dive Brief:​

• Coherus Biosciences, a maker of copycat biologic drugs, is getting into the business of developing new ones, announcing Monday a deal with Shanghai Junshi Biosciences for rights to a cancer immunotherapy that could compete with Merck & Co.'s Keytruda and Bristol Myers Squibb's Opdivo.
• Coherus will pay Junshi $150 million upfront under the deal. Junshi could receive $380 million more if the drug, called toripalimab, succeeds and certain development and sales milestones are met. The deal also gives Coherus option rights to several earlier stage cancer drugs for a fee of $35 million each.
• Coherus signaled the deal is the first step in a shift toward developing new cancer medicines using profits from its biosimilar business as funding. Chinese drugmakers like Junshi, meanwhile, have become sought-after partners for Western pharmaceutical companies like Eli Lilly and Novartis.

 

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Dive Insight:​

Coherus has proven successful at making biosimilar drugs. The company launched Udenyca, a cheaper alternative to Amgen's Neulasta in 2019 and, through the first nine months of last year, recorded $365 million in sales. In its biosimilar pipeline are copycat versions of Roche's cancer drug Avastin and eye medicine Lucentis as well as AbbVie's top-selling anti-inflammatory treatment Humira, each of which have annual sales measuring in the billions of dollars.

But the California-based company aims to expand beyond biosimilars and with Udenyca earning money, now has the cash flow to fund its plans. Junshi offered Coherus U.S. and Canadian rights to toripalimab, which is a type of cancer-fighting drug called a PD-1 inhibitor.

Six such drugs (or their close cousins) are approved in the U.S, but Merck's Keytruda is dominant, earning more than $10 billion from January through September last year. Its success has drawn competitors like Junshi, which has begun testing toripalimab in lung cancer, Keytruda's biggest market.

Toripalimab is already approved in China for treating melanoma under the brand name Tuoyi, which was the first domestically developed PD-1 blocker to be launched there. In the U.S., Junshi and Coherus this year hope to ask the Food and Drug Administration to approve the drug for use in treating patients with advanced nasopharyngeal carcinoma.

Executives portrayed the deal as the first step in a transition to "Coherus 2.0," which could be aided by the options included in the Junshi deal. For a fee, Coherus can pick up rights to earlier-stage drugs targeting cancer pathways called TIGIT and IL-2. The two companies are also in talks for two other immuno-oncology programs.

In partnering with Coherus, Junshi joins an array of Chinese immuno-oncology companies that have linked up with U.S. and European pharma companies on PD-1 drugs. Innovent Biologics signed a deal with Eli Lilly for rights to Tyvyt; BeiGene partnered with Novartis on its drug tislelizumab; and CStone is working with EQRx on development of sugemalimab.

 

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Junshi offered Coherus U.S. and Canadian rights to toripalimab, which is a type of cancer-fighting drug called a PD-1 inhibitor.

Checkpoint inhibitor drugs that target PD-1 or PD-L1​

PD-1 is a checkpoint protein on immune cells called T cells. It normally acts as a type of “off switch” that helps keep the T cells from attacking other cells in the body. It does this when it attaches to PD-L1, a protein on some normal (and cancer) cells. When PD-1 binds to PD-L1, it basically tells the T cell to leave the other cell alone. Some cancer cells have large amounts of PD-L1, which helps them hide from an immune attack.

Monoclonal antibodies that target either PD-1 or PD-L1 can block this binding and boost the immune response against cancer cells. These drugs have shown a great deal of promise in treating certain cancers.

https://www.cancer.org/treatment/tr...munotherapy/immune-checkpoint-inhibitors.html

 

[Cottonmouth]

Spam and rubbish.